Optimizing Duration and Threshold of Sensor Glucose for Identifying Symptomatic Hypoglycemia in Insulin-Treated Diabetes-Hypo-METRICS Study

Many episodes of hypoglycemia defined by the ATTD consensus are asymptomatic. We investigated if optimizing the glucose threshold and duration for sensor detected hypoglycemia (SDH) improves precision and sensitivity for identifying symptomatic hypoglycaemia from continuous glucose monitoring (CGM) data. We analysed 10 weeks of blinded CGM (Libre 2) and FitBit data from 435 participants [217 type 1, 218 type 2] with intact hypoglycemic awareness (Gold score <4). They self-reported symptomatic hypoglycemia on the Hypo-METRICS smartphone app. We used particle Markov chain Monte Carlo optimisation to generate the threshold and duration of SDH that maximizes detection of symptomatic hypoglycemia across our population and assessed impact of sleep status and diabetes type. The optimized threshold and duration were 70mg/dl for 27 min, with 2% gain of precision but 8% loss of sensitivity vs level 1 SDH (70mg/dl >15 min). Both level 1 SDH and our optimized definition had 3-fold increased sensitivity vs level 2 SDH (54mg/dl >15 min), with minimal loss of precision (Table). Our data validate ATTD level 1 hypoglycemia. Overall precision for detection of symptomatic hypoglycemia remains low despite optimization. Disclosure P.Divilly: None. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi, Vertex Pharmaceuticals Incorporated. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. J.K.Mader: Advisory Panel; Novo Nordisk A/S, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Medtronic, Becton, Dickinson and Company, Pharmasense, embecta, Research Support; A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Dexcom, Inc., Profusa, Inc., Speaker's Bureau; Novo Nordisk A/S, A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Boehringer Ingelheim Inc., Becton, Dickinson and Company, Ypsomed AG, Viatris Inc., Servier Laboratories, Medtrust, Stock/Shareholder; Decide Clinical Software GmbH. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. Hypo-resolve consortium: n/a. Z.Mahmoudi: Employee; Novo Nordisk. G.Martine-edith: Other Relationship; Novo Nordisk A/S. D.Boiroux: Employee; Novo Nordisk A/S. N.Zaremba: None. U.Soeholm: Employee; Novo Nordisk A/S. M.Gomes: Employee; Novo Nordisk A/S. A.A.Vaag: None. B.E.De galan: Research Support; Novo Nordisk. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)